Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia
NCT ID: NCT00872976
Last Updated: 2013-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2009-05-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort #1
Dasatinib
One Week Initial Treatment for Cohort #1: Dasatinib - Tablets/Oral Solution, at assigned dose level, once daily (QD)
Combination of Bendamustine + Dasatinib
Dasatinib, Tablets/Oral Solution, Oral, 50 mg, then at 80 mg, at 80 mg, and at 100 mg, once daily (QD), at assigned ascending dose, for 28 day cycles for a maximum of six cycles
Bendamustine, injection, IV injection, 50 mg/m²/Day 1 and Day 2, then at 50 mg/m², at 70 mg/m², at 70 mg/m², at assigned ascending dose, once daily 30 minute IV infusion Day 1 and Day 2 for a maximum of six cycles
Cohort #2
Dasatinib
One Week Initial Treatment for Cohort #2: Dasatinib - Tablets/Oral Solution, at 100 mg, once daily (QD)
Combination of Bendamustine + Dasatinib
Dasatinib, Tablets/Oral Solution, Oral, at 100 mg, once daily (QD), for 28 day cycles for maximum of six cycles
Bendamustine, injection, IV injection, 100 mg/m²/Day 1 and Day 2, once daily 30 minute IV infusion Day 1 and Day 2 for maximum of six cycles
Interventions
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Dasatinib
One Week Initial Treatment for Cohort #1: Dasatinib - Tablets/Oral Solution, at assigned dose level, once daily (QD)
Combination of Bendamustine + Dasatinib
Dasatinib, Tablets/Oral Solution, Oral, 50 mg, then at 80 mg, at 80 mg, and at 100 mg, once daily (QD), at assigned ascending dose, for 28 day cycles for a maximum of six cycles
Bendamustine, injection, IV injection, 50 mg/m²/Day 1 and Day 2, then at 50 mg/m², at 70 mg/m², at 70 mg/m², at assigned ascending dose, once daily 30 minute IV infusion Day 1 and Day 2 for a maximum of six cycles
Dasatinib
One Week Initial Treatment for Cohort #2: Dasatinib - Tablets/Oral Solution, at 100 mg, once daily (QD)
Combination of Bendamustine + Dasatinib
Dasatinib, Tablets/Oral Solution, Oral, at 100 mg, once daily (QD), for 28 day cycles for maximum of six cycles
Bendamustine, injection, IV injection, 100 mg/m²/Day 1 and Day 2, once daily 30 minute IV infusion Day 1 and Day 2 for maximum of six cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Require chemotherapy and have fully recovered from previous administered chemotherapy
* Subjects must have progressed, failed to achieve a meaningful response, or relapsed/intolerant to prior therapy. Failing at least one purine analogue regimen
* Subjects have received three or fewer prior treatment regimens
* ECOG status of 0 - 2
* If dose level + 3 is reached, the criteria is the same as outlined for Cohort #1, however the subjects should not have a history of prior chemotherapy (treatment naive)
Exclusion Criteria
* Uncontrolled or significant cardiovascular disease, including prolonged QTc interval
* History of significant bleeding disorder, unrelated to CLL
* Prior concurrent malignancy
* Drugs that generally accepted to have the risk of causing Torsades de Pointes
* Autoimmune hemolytic anemia requiring therapy or transfusion support
* Autoimmune thrombocytopenia requiring steroid therapy or transfusion support
* Richter's Syndrome
* Transformation to prolymphocytic leukemia
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
New Hyde Park, New York, United States
Local Institution
Columbus, Ohio, United States
Local Institution
Nashville, Tennessee, United States
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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CA180-182
Identifier Type: -
Identifier Source: org_study_id
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